'In genome Editas': Bosley signs off from CRISPR pioneer

CRISPR Nanoparticle
Just two months back, Editas got a $25 million check from Allergan for getting an FDA OK for its CRISPR trial. (MIT News)

Just a few months after getting the all-clear to start its first CRISPR trial and bagging a nice check from Allergan in the process, Editas Medicine’s chief executive and president, Katrine Bosley, is hitting the exit, and bringing down the biotech's shares in the process.

She’s also stepping down from the board and will be gone by March 1, but is staying on, as many a CEO does these days, as an “adviser” throughout 2019 to ensure a “smooth transition” for the next full-time CEO, a search for which is now underway. In the meantime, board member Cynthia Collins, and former (short-term) Human Longevity lead, will serve as CEO.

Why Bosley is leaving and whether she has another job lined up are not being made public. In a release, she said: “The team at Editas Medicine is making the future of medicine a reality. I’m very proud of them and all they have accomplished. I know they will keep driving forward to make unprecedented medicines to help people with serious diseases, and ones that may truly change patients’ lives. It has been a privilege to be part of Editas Medicine and to help pioneer this field, and I look forward to their continued success.”

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On Twitter, she added a little more, saying in a thread: “Dear friends & colleagues, Five years ago at Editas, we asked the (rather daunting) question, “What if you could repair broken genes?” The journey since then has been intense, exciting, and important.

“We’ve made great progress towards answering that question, with a lot of changes and transitions along the way. Today, I have news to share of another transition: this time, my own. I’ll soon be stepping down from my role as CEO.

“As many of you will understand, this was a tough decision. I believe in the mission; in our many unprecedented accomplishments; and, most of all, in the team of Editors we built. I wish them great success—it’s a really important mission.

“I’m proud of everything we achieved and built together, and I’ll always be cheering them on—now as Editas Emeritas, as we say. In genome Editas, Katrine.” Despite the positive notes, investors seemed spooked, sending shares down 22% by midday Tuesday. This also comes after a small exodus for the company; last year, its CMO and ex-Sanofi-Genzyme exec Gerald Cox also headed for the exit, with its CFO Andrew Hack joining him out the door late last year. All bad optics at the very least.

She leaves during a pivotal year for the gene-editing startup: Just two months ago, the FDA OK’d its IND application, seeing it start enrolling patients in a phase 1/2 trial of its CRISPR-based treatment for LCA10, a rare form of blindness.

Editas also collected a $25 million milestone payment from partner Allergan for hitting this early milestone.

It’s not been smooth sailing, however: Editas once expected to file the IND for its Allergan-partnered treatment EDIT-101 by the end of 2017.

But a manufacturing problem disclosed in May that year delayed those plans, allowing CRISPR Therapeutics and partner Vertex to get the jump on Editas. They kicked off a European trial of their ex vivo CRISPR-based treatment for beta thalassemia in August. But even Vertex and CRISPR have not been trouble-free—the FDA placed a clinical hold on their treatment, CTX001, in May, putting off their plans to start a clinical trial in sickle cell disease in the U.S. The agency lifted the hold back in October.

The setback came from a misstep in the production of a material used to make the adeno-associated viral vectors Editas will use to deliver its gene-editing treatment.

RELATED: CRISPR Therapeutics, Vertex start first company-backed human CRISPR trial

But, though Vertex and CRISPR nabbed the distinction of running the first company-backed CRISPR trial, Editas may yet get a first under its belt. EDIT-101 is slated to be the first in vivo CRISPR treatment tested in humans—that is, the gene editing takes place inside the body.

Vertex and CRISPR’s beta thalassemia treatment, on the other hand, involves ex vivo gene editing—a patient’s cells are harvested and edited to increase fetal hemoglobin levels in the patient’s blood cells. The edited cells are then infused back into the patient where they are expected to produce blood cells with fetal hemoglobin and compensate for defective adult hemoglobin.

There’s also been a long, sometimes bewildering patent battle over CRISPR ownership, and a number of other biotechs, including Intellia, CRISPR Therapeutics and others, are all vying to get in on the "next big thing" in biotech.

Thrown into the mix, too, have been potential ethical breaches by a Chinese scientist who reportedly used the gene-editing technique on babies who were brought to term, and several papers indicating that elements of the CRISPR technique could potentially be dangerous, hitting shares of all the biotechs involved.

Collins may have a lot to deal with this year, but is upbeat, adding: “I’m honored to take on the role of interim CEO during this important time for the Company. I look forward to working closely with Katrine and the talented Editas Medicine team to build on the momentum of the company’s recent successes, push the pace of innovation and accelerate our achievements for the benefit of those living with serious diseases.”

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